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Title:
IC-ECG MEASUREMENT SYSTEM
Document Type and Number:
WIPO Patent Application WO/2023/073636
Kind Code:
A1
Abstract:
The IC-ECG measurement system (10) comprises: a syringe (1), comprising: a hollow cylindrical body (2) defining a containment chamber (3) containing electrically conductive fluid for the IC-ECG measurement, comprising a syringe distal end (5), the syringe distal end (5) comprising an elongated hollow tip (5a) defining a passage channel (5b) a fluid displacement piston (6), mounted inside the fluid containment chamber (3) of the hollow cylindrical body (2) to push the fluid outwards from the syringe (1), and a venous catheter (11) provided with a first passage extremity (12) connected, in use, to the passage channel (5b) to receive the fluid and at least a second passage extremity (13) adapted to be arranged, in use, within a vena cava (14), and measuring means (15) of the IC-ECG, operationally connected to the catheter (11) and configured to measure the IC-ECG, wherein: a helical spring (8), the helical spring (8) being fitted so as to be compressed when the piston (6) is pulled, and so as to be elongated when the piston (6) is pushed, wherein the helical spring (8) is configured to reach a home position before the piston (6) has reached a bottom of the chamber (3) and before all the fluid contained in the chamber (3) has been pushed out of the elongated hollow tip (3), the piston (6), as a result of the decompression of the helical spring (8), pushes the fluid to fill the catheter (11).

Inventors:
BOURSIER NIUTTA STEFANO (IT)
DE LUTIO ENRICO (IT)
Application Number:
PCT/IB2022/060395
Publication Date:
May 04, 2023
Filing Date:
October 28, 2022
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
BCS S R L (IT)
EFG S R L (IT)
International Classes:
A61M5/20
Domestic Patent References:
WO2006078400A12006-07-27
WO2015054075A12015-04-16
WO1999020327A21999-04-29
WO2017046358A12017-03-23
Foreign References:
US20110071393A12011-03-24
US20130018248A12013-01-17
Attorney, Agent or Firm:
BRUNACCI, Marco (IT)
Download PDF:
Claims:
CLAIMS

1. IC-ECG measurement system (10), comprising: a syringe (1), comprising: a hollow cylindrical body (2) defining a containment chamber (3) containing electrically conductive fluid for the IC-ECG measurement, having a longitudinal axis (L), and comprising a syringe proximal end (4) and a syringe distal end (5), the syringe distal end (5) comprising an elongated hollow tip (5a) which extends distally therefrom and defining a passage channel (5b) for a fluid contained in the hollow cylindrical body (2) a fluid displacement piston (6), mounted inside the fluid containment chamber (3) of said hollow cylindrical body (2) in a sliding and fluid- tight engagement manner with the internal surface of said cylindrical body (2) to suck inwards to the syringe (1) and to push the fluid outwards from the syringe (1), the piston being coaxial to the cylindrical body (2) and comprising a piston proximal portion (6a) and a piston distal portion (6b), and a venous catheter (11) provided with a first passage extremity (12) connected, in use, in a fluid- operated manner, to said passage channel (5b) to receive the fluid and at least a second passage extremity (13) adapted to be arranged, in use, within a vena cava (14), the conductive fluid, in use, filling said catheter (11) to measure the IC-ECG, and measuring means (15) of the IC-ECG, operationally connected to said catheter (11) and configured to measure the IC-ECG, wherein: the syringe proximal end (4) comprises a lid (7) that partly encloses the hollow cylindrical body (2), said lid having a through hole (4a) having a through-span less than a cross-sectional area of the fluid containment chamber (3), the piston distal portion (6b) is configured to slide tightly into the fluid containment chamber and the piston proximal portion (6a) is fitted through said through hole (4a) and extends outwards from the syringe (1), a helical spring (8) is placed around said piston proximal portion (6a) and coaxial thereto, the spring (8) comprising a spring proximal end (8a) abutted against an internal surface of said lid and a spring distal end (8b) abutted against said piston distal portion (6b), said helical spring (8) being fitted so as to be compressed when the piston (6) is pulled to suck the fluid in the chamber (3) through the elongated hollow tip (5a), and so as to be elongated when the piston (6) is pushed to release a fluid present in the chamber (3) through the elongated hollow tip (5 a), wherein said helical spring (8) is configured to reach a home position before the piston (6) has reached a bottom of the chamber (3) and before all the fluid contained in the chamber (3) has been pushed out of the elongated hollow tip (3), said piston (6), as a result of the decompression of said helical spring (8), pushes the fluid to fill said catheter (11), so that the fluid pressure at the interface of said second passage extremity (13) is at least equal to or greater than that of the outside, thus preventing outside fluids from entering the inside of said catheter (11) and compromising the measurement of the IC-ECG.

2. System (10) according to claim 1, wherein said lid (7) is a hollow cylindrical body of uniform internal cross-sectional area and is coaxially constrained reversibly to said hollow cylindrical body (2).

3. System (10) according to claim 1 or 2, wherein said piston proximal portion (6a) is reversibly constrained to said piston distal portion (6b).

4. System (10) according to any one of the preceding claims, wherein said piston distal portion (6b) comprises an end tip (9) reversibly constrained to said piston distal portion (6b), the tip (9) being more flexible than said piston distal portion (6b) in the presence of a force directed distally from said piston distal portion (6b) onto said tip (9).

5. System (10) according to any one of the preceding claims, wherein the 18 piston proximal portion (6a) comprises a flange (6c), external to said hollow cylindrical body (2).

6. System (10) according to any one of the preceding claims, wherein said syringe (1) comprises a Luer-Lock type connector mounted where said elongated hollow tip (5 a) is located.

7. System (10) according to any one of the preceding claims, wherein said syringe (1) comprises opening and closing means (16) which are operable to release and obstruct the fluid passage through said passage channel (5b), said helical spring (8) remaining compressed when said opening and closing means (16) obstruct the fluid passage and being free to decompress when said opening and closing means (16) clear the fluid passage.

8. System (10) according to any one of the preceding claims, wherein said syringe (1) is pre-filled with the fluid to define a space (17) of gas between the piston (6) and the fluid level inside said chamber (3) and said spring (8) being compressed, said piston (6) being pulled, by expanding at least part of the gas contained within said space (17), to release the piston from the walls of said chamber (3).

9. Syringe (1), comprising: a hollow cylindrical body (2) defining a containment chamber (3) containing electrically conductive fluid for the IC-ECG measurement, having a longitudinal axis (L), and comprising a syringe proximal end (4) and a syringe distal end (5), the syringe distal end (5) comprising an elongated hollow tip (5a) which extends distally therefrom and defines a passage channel (5b) for a fluid contained in the hollow cylindrical body (2) a fluid displacement piston (6), mounted inside the fluid containment chamber (3) of said hollow cylindrical body (2) in a sliding and fluid- tight engagement manner with the internal surface of said cylindrical body (2) to suck the fluid inwards to the syringe (1) and to push the fluid outwards from the syringe, the piston being coaxial to the hollow body (2) and comprising a piston proximal portion (6a) and a piston 19 distal portion (6b), and the syringe (1) being characterized by the fact that the syringe proximal end (4) comprises a lid (7) that partly encloses the hollow cylindrical body (2), said lid having a through hole (4a) having a through-span less than a cross-sectional area of the fluid containment chamber (3), the piston distal portion (6b) is configured to slide tightly into the fluid containment chamber and the piston proximal portion (6a) is fitted through said through hole (4a) and extends outwards from the syringe (1), a helical spring (8) is placed around said piston proximal portion (6a) and coaxial thereto, the spring (8) comprising a spring proximal end (8a) abutted against an internal surface of said lid and a spring distal end (8b) abutted against said piston distal portion (6b), said helical spring (8) being fitted so as to be compressed when the piston (6) is pulled to suck the fluid in the chamber (3) through the elongated hollow tip (5a), and so as to be elongated when the piston (6) is pushed to release a fluid present in the chamber (3) through the elongated hollow tip (5 a), wherein said helical spring (8) is configured to reach a home position before the piston (6) has reached a bottom of the chamber (3) and before all the fluid contained in the chamber (3) has been pushed out of the elongated hollow tip (3), said piston (6), as a result of the decompression of said helical spring (8), pushes the fluid outside said passage channel (5b).

10. Method of detecting the position of a venous catheter by means of IC-ECG measurement system, comprising at least the steps of: supply of an IC-ECG measurement system (10) according to one or more of claims 1 to 8; measurement of IC-ECG by means of said measuring means (15); detection of the position of said second passage extremity (13) of the 20 catheter (11) along the vena cava (14) depending on the measured IC-ECG.

Description:
IC-ECG MEASUREMENT SYSTEM

Technical Field

The present invention relates to an IC-ECG measurement system which uses a syringe provided with a spring to move the piston.

Background Art

Common medical practice very frequently requires the injection or taking of larger or smaller amounts of fluid to a subject, e.g., for therapeutic and/or diagnostic purposes. These fluids comprise, e.g., anesthetics to be injected in the proximity to the body area to be treated. A syringe generally consists of a tube, a piston capable of sliding into the tube and a plunger actuated to move the piston in the proximal direction and thereby to exert a suction force on a fluid, e.g., a medicinal fluid so that it flows into the tube through a distal opening of the same and in the distal direction to guide the same fluid outwards through the same distal opening. A known needle, tube or other medical device suitable for the final application of the syringe may be mounted where the distal opening of the syringe tube is located.

Some commercially available syringes implement resistance means adapted to regulate the movement of the piston in order to calibrate the amount of fluid fed into the tube. Typically, such syringes employ thrust springs to return the fluid displacement piston to its original position after being pressed into the fluid displacement position.

US 2018/0353676 patent application describes syringes, implementing springs external to the syringe barrel to push the piston to an extended position, but which are bulky and difficult to use. Such devices are limited by the fact that the stress mechanisms are not suitable for conventional syringes. In addition, these devices are inconvenient to use, mainly because of the mechanical encumbrance caused by the implementation of a spring outside the syringe tube. In fact, a serious drawback of these devices is the operation of the device in close proximity to the body, which is obstructed by the protruding spring and by any handles. The construction of such devices is correspondingly complex and expensive, and therefore does not allow for the implementation of disposable devices.

In addition, the syringes on the market are inconvenient to use in the field of intra-cavitary electrocardiography, particularly in performing the Intracavitary Electrocardiogram (IC-ECG) method for “tip location” in the placement of Central Venous Catheters (CVCs) by using the technique of catheter filled with conductive fluids, such as e.g. saline solution, so as to make the catheter conductive. Currently, such syringes are still used to fill the catheter, but skilled personnel are needed so that there are no artifactual changes in the electrocardiogram tracing due to baseline fluctuations in the IC-ECG.

Description of the Invention

The technical problem posed and solved by the present invention is, therefore, to provide an IC-ECG measurement system that makes use of an improved syringe compared to the devices known in the art, i.e., that does not have the above-mentioned drawbacks, and the essential characteristics of which are as defined in the appended claim 1. Other ancillary technical characteristics are the subject of the dependent claims.

A first object of the present invention is to provide an IC-ECG measurement system using a syringe defined by the assembly of several components reversibly assembled together to allow for interchangeability of the components. Said components comprise a hollow cylindrical body defining a fluid containment chamber and provided with an elongated hollow tip for the fluid passage where its distal end is located, and an end lid coaxially constrained reversibly to the hollow cylindrical body where its proximal end is located and provided with a through gap for the passage of a piston. The piston, in turn, comprises a piston proximal portion, reversibly constrained to a piston distal portion configured to slide into the fluid containment chamber in a fluid- tight manner.

According to another aspect, the present invention solves the aforementioned technical problem by providing the IC-ECG measuring system that makes use of a syringe wherein a helical spring is installed coaxial to the piston proximal portion and abutted against an internal surface of said lid and against the piston distal portion. The spring is configured so as to be compressed when the piston is pulled to suck a fluid into the fluid containment chamber of the syringe.

As will be evident to an engineer in the field, the spring-loaded syringe covered by the present invention advantageously provides control of the pressure exerted by the piston on the fluid contained in the syringe, so that the spring reaches a home position before the piston has pushed all the fluid contained therein out of the syringe.

It is a further object of the present invention to provide an IC-ECG measurement system that makes use of a solution implementing a spring coaxial to the piston of a common syringe.

Other aspects, characteristics and advantages of the positioning system and method referred to in the present invention will be evident from the detailed description below.

Brief Description of the Drawings

By way of example, an embodiment of the syringe of the invention is presented, referring to the attached drawings, wherein:

Figure 1 is an exterior front view of a syringe according to an embodiment of the invention,

Figure 2 is a frontal cross-sectional view of the syringe shown in Figure 1, Figure 3 is a frontal cross-sectional view of the syringe shown in Figures 1 and 2 during a fluid suction phase,

Figure 4 is a schematic view of the system according to the invention.

The thicknesses and dimensions shown in the Figures introduced above should be understood as purely illustrative, are generally magnified and not necessarily shown in proportion.

Embodiments of the Invention

In the detailed description that follows, further embodiments and variants to embodiments and variants already covered in the same description will be shown limited to differences with what has already been set forth. In addition, the different embodiments and variants described below are all likely to be used in combination, where compatible. As shown in the figures, the IC-ECG measurement system using a spring- loaded syringe according to the present invention is generally referred to as reference number 10.

In its simplest embodiment, the IC-ECG measurement system 10 is provided with a syringe 1 which comprises a hollow cylindrical body 2 defining a containment chamber 3 containing electrically conductive fluid for the IC-ECG measurement, having a longitudinal axis L, a syringe proximal end 4 and a syringe distal end 5.

Preferably, the electrically conductive fluid is of the type of a saline solution at any title, such as e.g. a physiological solution.

The syringe distal end 5 in turn comprises an elongated hollow tip 5a which extends distally therefrom and defines a passage channel 5b for a fluid intended to be fed to fill the hollow cylindrical body 2, to be precise within the fluid containment chamber 3.

According to one embodiment of the present invention, the syringe 1 may optionally comprise a Luer-Lock type connector mounted where said elongated hollow tip 5a is located in a concentric manner thereto. The internal surface of the connector may comprise one or more threads to allow an external operator to reversibly engage a needle assembly, cannula, or other suitable medical device, not shown in the figure, so as to set the chamber 3 of the hollow cylindrical body 2 in fluid communication with the lumen of, e.g., a cannula or a needle.

Also part of the syringe 1 is a fluid displacement piston 6 mounted inside the fluid containment chamber 3 of the hollow cylindrical body 2, to which it is coaxial, in a sliding and fluid-tight engagement manner with the internal surface of the cylindrical body 2. The function of the piston 6 is to suck inwards to the syringe 1 and to push the fluid outwards from the syringe 1, when the piston 6 is pulled in the proximal direction and pushed in the distal direction respectively, such as e.g. by an external operator or by the spring 8, as will be described later in this disclosure.

Specifically, the piston 6 comprises a piston proximal portion 6a and a piston distal portion 6b, wherein the piston proximal portion 6a has a smaller diameter than the piston distal portion 6b and is preferably reversibly constrained thereto. The distal portion 6b has a diameter substantially equal to the internal diameter of the hollow cylindrical body 2 and is configured to slide in a fluid-tight manner into the fluid containment chamber 3. The piston distal portion 6b comprises an end tip 9 reversibly constrained thereto in the distal position. Said tip 9 is in direct contact with the fluid contained in the chamber 3 and is configured to push said fluid outwards from the syringe when the piston 6 is depressed, e.g. by the external operator or by the spring 8. Preferably, the end tip 9 may comprise one or more ring seals that extend in a radial pattern to prevent fluid from bypassing the tip 9 when the piston 6 is depressed and made to slide into the chamber 3.

Fluid tightness is ensured by the fact that the ring seals have a diameter slightly larger than the internal diameter of the hollow cylindrical body so that they are slightly deformed when fitted into the hollow cylindrical body. The end tip 9 also has a fluid displacement surface facing axially in the direction of the syringe distal end. Said surface preferably has a conical profile to fit the end surface of the fluid containment chamber 3, as with the ordinary syringes, and to facilitate pushing the fluid through the passage channel 5b.

Advantageously, the end tip 9 is made of a more flexible material than the piston distal portion 6b in the presence of a force directed distally from the distal portion 6b onto the tip 9. For example, the end tip 9 can be made of natural rubber, synthetic rubber, silicone, polyurethane or any flexible material. In this way, when the piston 6 is pushed in the distal direction, e.g. by the external operator or by the spring 8, the force applied to the piston distal end does not cause plastic distortion of the end tip 9 due to the fluid-tight structure, and the end tip 9 is free to flex in response to the force.

According to one embodiment, the piston proximal portion 6a may, in turn, comprise a flange 6c, external to said hollow cylindrical body 2, configured to facilitate the grip and handling of the piston 6 by an external operator.

In a preferred embodiment of the present invention, the syringe 1 is made so that the syringe proximal end 4 comprises a lid 7 that partly encloses the hollow cylindrical body 2. The lid 7 is preferably a hollow cylindrical body of uniform internal cross-sectional area and having an internal diameter equal to that of the hollow cylindrical body 2, and is coaxially constrained reversibly to said hollow cylindrical body 2, e.g. by means of threading, interlocking or any other method known in the art.

Said lid 7 is characterized by a through hole 4a having a through-span less than a cross-sectional area of the fluid containment chamber 3, such that the piston proximal portion 6a is fitted through said through hole 4a so that it can slide through it and extend outwards from the syringe 1.

Preferably, the lid 7 may comprise, in the proximal position, one or more flanges 7a configured to facilitate one-handed syringe gripping in synergy with said flange 6c of the piston 6.

A helical spring 8, preferably with congruent coils, that is, coils having the same distance from each other so that the spring pitch is constant, is placed around said piston proximal portion 6a and is coaxial thereto.

As shown in Figures 2 and 3, the spring 8 comprises a spring proximal end 8a abutted against an internal surface of said lid 7 and a spring distal end 8b abutted against the piston distal portion 6b. As it is fitted, it is appreciated that the spring 8 is never wetted by the fluid contained in the syringe while always remaining confined within the hollow cylindrical body 2 of the syringe.

The helical spring 8 is fitted so as to be compressed when the piston 6 is pulled to fill the chamber 3 with the fluid, e.g. a saline solution, through the elongated hollow tip 5a, and so as to be elongated when the piston 6 is pushed to release a fluid present in the chamber 3 through the elongated hollow tip 5a.

Advantageously, the helical spring 8 is configured to reach a home position before the piston 6 has reached a bottom of the chamber 3 and before all the fluid contained in the chamber 3 has been pushed out of the elongated hollow tip 5a.

This allows a residual volume of fluid to be contained within the chamber 3 at all times and allows facilitating the achievement of the hydrostatic equilibrium at the interface of the elongated hollow tip 5a or at the distal interface of a catheter 11 connected to the syringe 1, as will be described later in this disclosure.

In fact, the residual fluid volume ensures that the hydrostatic equilibrium is reached before the spring 8 is completely discharged, thus ensuring that the catheter 11 always remains full of fluid as will be better described later in this description.

Advantageously, the piston distal portion 6b evenly distributes the piston thrust force on the end tip 9, particularly in the presence of a thrust force applied, e.g. by the external operator or by the spring 8, to the piston 6 in the distal direction. In this way, the piston distal portion 6b prevents the ring seals of the end tip 9 from being deformed, which are therefore kept intact regardless of the thrust force exerted, without affecting the soundness of the fluid seal.

According to one embodiment of the present invention, the spring 8 can be selected for its geometrical characteristics so that its external helical diameter is equal to the internal diameter of the hollow cylindrical body 2. Alternatively, the spring can be selected so that its internal helical diameter is equal to the diameter of the piston proximal portion 6a. It will be obvious to the expert in the technical branch that, depending on the size of the diameter of the piston proximal portion 6a, it is possible to select a spring that meets both of the above requirements, i.e., a spring with an external helical diameter equal to the internal diameter of the hollow cylindrical body 2 and with an internal helical diameter equal to the diameter of the piston proximal portion 6a.

The spring constant can be selected appropriately so that the spring will overcome the frictional resistance between the piston 6 and the inside of the hollow cylindrical body 2, e.g., the friction generated by the sliding of the piston distal portion 6b or that generated by the ring seals for the fluid tightness of the end tip 9, either when the piston is pushed or when the piston is retracted. The spring 8 is preferably made of chemically inert metal or metal alloy such as stainless steel or any other material known in the art that meets the compatibility requirements with medical devices. In a preferred embodiment of the present invention, the system 10 comprises a venous catheter 11 provided with a first passage extremity 12 connected, in use, in a fluid- operated manner, to the passage channel 5b to receive the fluid and at least a second passage extremity 13 of the fluid adapted to be arranged, in use, within a vena cava 14, the conductive fluid, in use, filling the catheter 11 to measure the IC-ECG.

In particular, the second passage extremity 13 is adapted, in use, to be connected with the outside in a fluid- operated manner, such as e.g. with the vena cava 14 when fitted within the latter.

In addition, the system 10 comprises measuring means 15 of the IC-ECG, operationally connected to the catheter 11 and configured to measure the IC- ECG.

Preferably, the measuring means 15 are of the type of known electronic measuring means that employ at least the same fluid- filled catheter 11 as the measuring electrode.

In particular, when the catheter 11 remains filled, preferably only by fluid, it properly serves as an electrode for the measuring means 15.

Advantageously, the piston 6, as a result of the decompression of the helical spring 8, pushes the fluid to fill the catheter 11, so that the fluid pressure at the interface of the second passage extremity 13 is at least equal to or greater than that of the outside (e.g., that of the blood flowing in the vena cava 14), preventing outside fluids (e.g., the blood itself) from entering the inside of the catheter 11 and compromising the measurement of the IC-ECG.

In more detail, the piston 6, as a result of the decompression of the helical spring 8, pushes the fluid to fill the catheter 11 until the fluid pressure at the interface of the second passage extremity 13 is substantially equal to that of the outside (e.g., that of the blood flowing in the vena cava 14), preventing outside fluids (e.g., the blood itself) from entering the inside of the catheter 11 and compromising the measurement of the IC-ECG.

In more detail, the piston 6, as a result of the decompression of the helical spring 8, initially pushes the fluid into the catheter 11, filling it completely with fluid and freeing it of any other liquids or gases contained therein. At this stage, some of the fluid fed into the catheter 11 from the syringe 1 exits the second passage extremity 13 until the fluid pressure at the interface of the second passage extremity 13 substantially equals the fluid pressure outside the catheter 11 (such as, e.g., the pressure of the blood flowing within the vena cava 14 into which the second passage extremity 13 of the catheter 11 is adapted to be fitted), that is, when, at the interface of the second passage extremity 13, the fluid inside the catheter and the fluid outside the catheter reach hydrostatic equilibrium.

In this way, the spring 8 gradually decompresses and discharges without, however, decompressing and discharging totally. In fact, the pressure of the external fluid actuating at the interface with the second passage extremity 13 prevents the spring 8 from totally decompressing and unloading.

In fact, when the chamber 3 is emptied of fluid, the spring 8 reaches the home position, that is, it is totally decompressed and unloaded, before the piston 6 has reached the bottom of the chamber 3.

Conveniently, the syringe 1 comprises opening and closing means 16 which are operable to clear and obstruct the fluid passage through the passage channel 5b. Specifically, the helical spring 8 remains compressed when the opening and closing means 16 obstruct the fluid passage and is free to decompress when the opening and closing means 16 clear the fluid passage until, at the interface of the second passage extremity 13, the fluid within the catheter and the fluid outside the catheter reach the hydrostatic equilibrium.

In this way, when the opening and closing means 16 are activated to clear the fluid passage, the helical spring 8 is free to decompress and pushes the piston 6, so that fluid is fed inside the catheter 11.

This allows an initial prime that clears the catheter of any residual fluid or air and ensures that it is filled only with fluid until, at the interface of the second passage extremity 13, the fluid inside the catheter and the fluid outside the catheter reach the hydrostatic equilibrium.

Preferably, the opening and closing means 16 are manually operable. Preferably, the opening and closing means 16 are of the type of a tap mounted on the syringe 1 or clamp.

The syringe 1 according to the present invention is configured to switch from a first operating configuration to a second and third operating configuration.

Before use, as shown in Figure 2, when the syringe is in said first operating configuration, the helical spring 8 is in a home position and the piston is in a home position within the hollow cylindrical body 2 so that the end tip 9 is spaced apart from the ending surface of the chamber 3 thus defining a gap 3 a, meant as the space interposed between the ending surface of the chamber and the end tip.

In a preliminary phase of loading the syringe 1, the external operator can load the chamber 3 by sucking a certain amount of fluid, e.g. a saline solution. For example, after engaging a needle at the elongated hollow tip 5a, preferably using the Luer-Lock connector, the operator can employ the needle to perforate the membrane of a common medicinal liquid bottle and apply pressure to the piston 6 so as to push it completely in the distal direction thus bringing it to a position of maximum thrust and cause the end tip 9 to be in contact with the ending surface of the chamber 3.

By retracting the piston 6, a suction force is generated that brings the fluid into the chamber 3.

The volume of fluid fed into the syringe is such that it fills said gap 3 a and constitutes the residual volume characterizing the syringe 1.

After the preliminary loading phase is completed, the syringe is again in the first operating configuration, wherein the helical spring 8 and the piston 6 are in the home position, with a defined residual volume of fluid contained in the gap 3a of the syringe chamber 3. At this point, the operator can continue to fill the syringe with a further volume of the same, or another fluid by bringing the syringe 1 into a third operating configuration, or dispense all, or part, of the residual volume of fluid, as explained in detail in the following paragraphs.

If required, the operator can perforate again the first bottle, a new bottle or a blood vessel and bring the syringe into a third operating configuration by exerting a pulling force on the piston, using a one-handed grip facilitated by the flanges 6c and 7a, to suck a given volume of fluid.

According to an optional aspect, the external surface of the hollow cylindrical body 2 of the syringe 1 can be provided with calibration marks indicating the volume contained within the fluid containment chamber 3 depending on the position of the piston 6.

A further advantage of the presence of a residual volume of fluid in the syringe is the facilitation for the operator of the fluid collection process which, with ordinary syringes, often requires the elimination of air bubbles that have penetrated into the syringe due to inadvertent piston movements. The use of a syringe according to the present invention, containing a residual volume of fluid, reduces the risk of the introduction of air bubbles into the syringe chamber because the fluid containment chamber 3 is already partly filled with a residual volume of fluid.

When the syringe 1 is in the third operating configuration, as shown in Figure 3, the spring 8 will be compressed and, once the chamber 3 is filled with the required volume of fluid, the operator can pull out the needle and continue holding the syringe 1, ready for use.

Further embodiments of the system 10 cannot however be ruled out wherein the syringe 1 remains in the third operational configuration thanks to the opening and closing means 16 that obstruct the fluid passage.

Further embodiments of the system 10 cannot either be ruled out wherein the syringe 1 is pre-filled with the fluid to define a space 17 of gas between the piston 6 and the fluid level inside the chamber 3 and the spring 8 is compressed, and wherein the piston 6 is pulled, by expanding at least part of the gas contained within the space 17, to release the piston itself from the walls of the chamber 3.

Preferably, the gas is air.

In other words, in this embodiment, the syringe 1 is provided already pre-filled with the fluid to define the space 17.

Preferably, the term pre-filled syringe means that the syringe has been filled and stored for use even after a long time.

In fact, pre-filled syringes may remain unused for a long period of time during which the piston 6 may “stick” to the walls of the chamber 3.

Therefore, before using the pre-filled syringe 1, it should be ensured that the piston is free to slide inside the chamber 3.

Therefore, due to the ability of the gas to expand, the piston 6 is pulled just enough to ensure that it is released, without the syringe 1 losing its functionality and effectiveness.

In fact, without the space 17 of air it would not be possible to pull the piston, which, therefore, could only be pushed. However, this would waste part of the decompression stroke of the spring 8 and useful fluid to the system 10.

In particular, the space 17 must be of a size that allows the piston 6 to be pulled by at least one millimeter.

In use, to fill the catheter 11 of fluid contained in the chamber 3 when the syringe 1 is in the third operating position, it is not necessary for the operator to apply a thrust force on the piston 6. In fact, by releasing the piston 6, the elastic response of the compressed spring 8 tends to push the piston distal portion 6b and to generate a force in the distal direction so that the end tip 9 pushes the fluid contained in the chamber 3 outwards through the passage channel 5b.

These characteristics make it particularly advantageous to use the syringe of this disclosure to perform IC-ECG for catheter tip placement. For this purpose, the syringe is connected to the catheter 11 fitted into the vena cava (typically the superior vena cava) of a patient, and the piston 6 of the syringe 1 is released so that the compressed spring 8 moves the piston 6 forward. In this way, there is an initial injection of liquid into the catheter 11 that clears it of the patient’s blood and gives it more rigidity by filling it with fluid. Due to the fact that the home position of the spring 8 is reached when the syringe 1 is not completely emptied, with the syringe 1 of the present disclosure, fluid is maintained in the syringe - and thus the fluid that fills the catheter 11 used for “tip location” - at a pressure that equals the pressure in the blood vessel, regardless of the fact that the pressure varies from patient to patient. In fact, the piston 6 will stop when the opposing pressure of the blood equals the residual pressure of the spring 8, so with this syringe 1 the ideal condition for performing IC-ECG is automatically achieved, i.e., a catheter that is filled only with fluid at a pressure such that, once fitted, it can reach hydrostatic equilibrium with the pressure in the blood vessel.

Advantageously, the catheter 11 filled in this way, once hydrostatic equilibrium has been reached, remains filled, preferably without releasing further fluid, and serves as an electrode for IC-ECG measurement.

With the syringe of the present disclosure, even inexperienced personnel will be able to perform an IC-ECG without generating undesirable fluctuations in the reference potential, because all they have to do is connect the pre-filled syringe to the catheter and then connect the catheter, e.g., via special electrical connectors, to the measuring means 15 of the IC-ECG.

When the syringe 1 is again in the first operating configuration, the operator may decide, based on needs, to dispense part or all of the fluid residual volume by applying pressure to the piston 6 so as to push it further in the distal direction by bringing the end tip 9 closer to the ending surface of the chamber 3, by pushing the fluid residual volume outwards through the passage channel 5b, possibly bringing the syringe into the second operating configuration, with the piston 6 in the position of maximum thrust and the end tip 9 in contact with the ending surface of the chamber 3, thus dispensing all the residual volume of fluid and by emptying the chamber 3.

According to a further aspect, the present invention relates to a syringe 1 comprising a hollow cylindrical body 2 defining an electrically conductive fluid containment chamber 3 for the measurement of IC-ECG, having a longitudinal axis L, and comprising a syringe proximal end 4 and a syringe distal end 5.

Specifically, the syringe distal end 5 comprises an elongated hollow tip 5a extending distally therefrom and defining a passage channel 5b for a fluid contained in the hollow cylindrical body 2.

In addition, the syringe 1 comprises a piston 6 for the fluid displacement which is mounted within the fluid containment chamber 3 of the hollow cylindrical body 2 in a sliding manner in fluid-tight engagement with the internal surface of the cylindrical body 2 to suck the fluid inwards to the syringe 1 and to push the fluid outwards from the syringe 1, the piston being coaxial to the cylindrical body 2 and comprising a piston proximal portion 6a and a piston distal portion 6b.

Also, with reference to the syringe 1 : the syringe proximal end 4 comprises a lid 7 that partly encloses the hollow cylindrical body 2, the lid having a through hole 4a having a through-hole span smaller than a cross-sectional area of the fluid containment chamber 3, the piston distal portion 6b is configured to slide tightly into the fluid containment chamber, and the piston proximal portion 6a is fitted through the through hole 4a and extends outwards from the syringe 1, a helical spring 8 is placed around the piston proximal portion 6a and coaxial thereto, the spring 8 comprising a spring proximal end 8a abutted against an internal surface of the lid and a spring distal end 8b abutted against the piston distal portion 6b, the helical spring 8 being installed so as to be compressed when the piston 6 is pulled to suck the fluid into the chamber 3 through the elongated hollow tip 5 a, and so as to be elongated when the piston 6 is pushed to release a fluid present in the chamber 3 through the elongated hollow tip 5a, wherein the helical spring 8 is configured to reach a home position before the piston 6 has reached a bottom of the chamber 3 and before all the fluid contained in the chamber 3 has been pushed out of the elongated hollow tip 5a.

Advantageously, the piston 6, as a result of the decompression of the helical spring 8, pushes the fluid out of the passage channel 5b.

It cannot, however, be ruled out that the syringe 1 has one or more of the characteristics listed in the description of the system 10 with reference to the syringe 1.

Furthermore, what said about the hydrostatic equilibrium with reference to the interface of the second passage extremity 13 is also considered valid for the interface between the elongated hollow tip 5a of the syringe 1, when the same is not connected to the catheter 11.

According to a further aspect, the present invention relates to a method of detecting the position of a venous catheter by means of IC-ECG measurement system, comprising at least the steps of: supply of an IC-ECG measurement system 10; measurement of IC-ECG by means of the measuring means 15; detection of the position of the second passage extremity 13 of the catheter 11 along the vena cava 14 depending on the measured IC-ECG.

In particular, the detection of the second passage extremity 13 along the vena cava 14 is performed depending on the wave P of the IC-ECG.

In fact, the amplitude of the wave P provides an indication of the position of the second passage extremity 13 with respect to the heart.

According to the invention, the method just described comprises one or more of the processes described or directly derivable with reference to the system 10 described above.

The aforementioned procedures for use have been given by way of example and are not limiting. It is understood that the system, according to any of the embodiments described herein may be employed for other uses obvious to a technician in the field, particularly for uses that take advantage of the characteristics described herein, even if not expressly stated in this description.

The present invention has been described herein with reference to its preferred embodiments. It is to be understood that other forms of embodiment may exist or be contemplated which share the same inventive core with the one described herein, all of which fall within the scope of protection of the claims below.